ADAR POONAWALLA, CEO of Serum Institute of India (SII), on Friday said they were building a facility to make mRNA vaccines, even as SII was scaling up its production of Covishield vaccines from the present 160 million doses monthly to 200 million doses from October.
While the facility for mRNA vaccines will take two years to be completed, this infrastructure will be available for two companies — Serum Institute Life Sciences Limited (SILS) and Biocon Biologics Limited —which have recently entered into a long-term partnership.
Poonawalla and Kiran Mazumdar Shaw, executive chairperson, Biocon and Biocon Biologics (BBL) addressed a virtual media conference on Friday to announce their strategic alliance.
As part of this alliance, BBL will have access to 100 million doses of vaccines annually for 15 years and commercialisation rights of the SILS vaccine portfolio for global markets. SILS will receive approximately a 15 per cent stake in BBL, based on a valuation of about $4.9 billion.
“This alliance will allow us to combine our strengths in biologics and vaccines for making a meaningful impact in fighting infectious diseases. In addition to vaccines, the alliance will also develop antibodies targeting several infectious diseases like dengue and HIV,” Shaw said.
Poonawalla said that within this framework of the partnership, there were several opportunities that they could explore.
“For instance, the mRNA technology… we are building a facility to at least handle a few 100 million doses — this will take two years to build but till then, BBL does its research and gets the products, which we can manufacture and share the profits. These are add-ons that will happen over the years. There are limitations with mRNA technology related to long term efficacy. If we do embark on an mRNA candidate, then it should be at a stable temperature of 2 to 8 degrees and not minus 70 degrees,” Poonawalla said while responding to a query.
Poonawalla admitted that people may be wondering why they had arrived at this alliance now. “We have known each other for decades and never has there been a time when the opportunities have been so great globally to leverage our skill sets in manufacturing and research. In 2020, I had to make a difficult decision where I had to put off plans temporarily for our monoclonals and the capacities we had built. All that was sacrificed for manufacturing Covishield doses. We are producing and delivering 160 million Covishield doses every month to the country. This will soon be expanded to 200 million doses from October. We are now hoping to maintain our ambitions in the biologic space,” he said.
Ramping up production to 200 million doses of Covishield per month will also be based on the raw material that SII gets from the global raw material supply chain. Poonawalla said that there has been an improvement since March on the supply front of raw materials.
According to Shaw, they were keen on being self-reliant. “We do not want supply chain disruptions and hence the effort is to build the entire supply chain in the country. We do not have to rely on external vendors is what Adar and I strongly feel,” Shaw said.
The duo is also keen on backward acquisitions for raw materials. “We are now going to discuss and explore common items of raw materials and shortlist four or five major items — bio-reusable bags and others where a focussed strategy can be worked upon,” Poonawalla added.
On lifting of export restrictions, Poonawalla hoped that it would ease out within the next two months. “Considering the fact how many vaccines we have delivered and others in India have delivered, we are coming very close to a point where there is more than enough vaccine stock especially now with us scaling even further for this year. In the next two months, we do expect a slow easing of export restrictions. However, we will go by what the GoI thinks is appropriate as they need to balance the stockpiling of vaccines in case of future third and fourth waves. Taking lessons that we learnt in the second wave that hit India badly, we don’t want to be in that situation again and that is why the Indian government is being cautious in managing the vaccine stocks,” Poonawalla said.
On booster shots, Poonawalla said that the jury was still out on that issue. “There is no evidence to say so far that Covishield requires a third dose — some people who want to take it may have taken the dose. We have not officially recommended and DCGI and ICMR will have to decide, including how effective the vaccine is against the delta variant. Some vaccines in the West have reported a drop in the antibody response and hence they have been recommending a third dose.
However, the main goal is to give both doses to everybody and then look at the third dose as a booster as it is unethical to give somebody the third dose when others in certain countries and populations have not been given two doses. While only 2 to 3 per cent of developing world countries have received vaccines, it has gone up to 40-50 per cent in the developed world.
Rich nations have taken away most of the vaccines and are talking about giving a third dose which is not right till a significant part of other countries gets two doses. Till such time we can look at a booster shot which will eventually happen, from an ethical standpoint we must focus on strategies in this manner,” he said.
When asked whether fully vaccinating all eligible beneficiaries in India by the year-end was an achievable target, Poonawalla said he did not want to guess. “Everyone in the pandemic I guess has been regretting making statements. So I do not want to guess. We will be supplying 200 million doses from October. Bharat Biotech has been scaling up production and with Zydus contributing, hopefully, we can cover a large part of the population so that we are prepared in the event of any other wave. What we have achieved as a country has been phenomenal given our population size,” he said.
“This is a unique partnership as two large Indian companies have got together. The bigger opportunity lies in vaccines and novel antibodies to treat Covid-19,” Shaw added while noting that they were heading towards vaccine adequacy. “By the end of the year, we will be in a good place. Even if there is another wave, it will be muted,” Shaw added.